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The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine (Uranic)

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ClinicalTrials.gov Identifier: NCT02558023
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The objective of this study is to demonstrate that urapidil is not inferior to nicardipine for the treatment of hypertension associated with preeclampsia (PE) and that it is better tolerated.

  • efficacy endpoint : mean arterial blood pressure corrected to 100-120 mmHg after 120 min of study drug administration.
  • safety endpoints : clinical and biological observation for any side effect. All infants will be observed in the neonatology unit (during 48h).

Pharmacokinetic study included to study :

  • transplacental transfer,
  • transfer in breast milk,
  • and neonatal elimination (premature babies of mothers treated with urapidil (less than 33 WG))

Condition or disease Intervention/treatment Phase
Hypertension Preeclampsia Drug: Urapidil Drug: Nicardipine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Treatment of Hypertension Associated With Severe Preeclampsia. A Randomize Controlled Trial of Urapidil Versus Nicardipine. The Uranic Trial
Actual Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Urapidil

Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.

The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.

Maximum dose of 30 mg.h-1.

Drug: Urapidil

Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.

The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.

Maximum dose of 30 mg.h-1.


Active Comparator: Nicardipine

Nicardipine : IV

1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.

Maximum dose of 6 mg.h-1

Drug: Nicardipine

Nicardipine : IV

1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.

Maximum dose of 6 mg.h-1





Primary Outcome Measures :
  1. Blood pressure at two hours [ Time Frame: up to 4 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients
  • Singleton pregnancy
  • Patients with remaining hypertension despite an oral treatment for who an iv antihypertensive treatment is indicated

Patient with PE, as defined by :

  • Systolic Blood Pressure (BP) ≥ 140 mmHg and/or Diastolic BP ≥ 90 mmHg, after the 20th week of amenorrhea, without chronic hypertension, AND
  • Proteinuria > 300 mg.day-1 or > 2 crosses(++) on an urinary dipstick,

OR

Patient with severe Pregnancy Induced Hypertension (PIH), as defined by :

Systolic BP ≥ 160 mmHg and/or Diastolic BP ≥110 mmHg, after the 20th week of amenorrhea, without chronic hypertension,

  • Written informed consent signed and dated by both investigator and patient,
  • Valid social security affiliation

Exclusion Criteria:

  • Known allergy to study drugs
  • Contra-indication to the study drugs: stenosis of the aortic isthmus, arteriovenous shunt, coarctation of the aorta, unstable angina, compensatory hypertension, myocardial infarction < 8 days.
  • Eclampsia
  • Person with difficulty understanding information
  • Person with diminished responsibility,
  • Ongoing intravenous antihypertensive treatment,
  • No pressure cuff adapted to the morphology of the arms of the patients
  • Concomitant use of 5 phosphodiesterase inhibitors
  • Participation in a clinical trial within 6 months prior to inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558023


Contacts
Contact: Pierre DIEMUSCH, PUPH 33.3.88.12.70.78 pierre.diemunsch@chru-strasbourg.fr

Locations
France
Service d'Anesthésie - CMCO Not yet recruiting
Schiltigheim, France, 67303
Contact: Pierre DIEMUNSCH, MD.PH         
Sub-Investigator: Rita VIZITIU, MD         
Sub-Investigator: Valentina FAITOT, MD         
Service d'Anesthésie et de Réanimation Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Pierre DIMUNSCH, PUPH    33.3.88.12.70.78    pierre.diemunsch@chru-strasbourg.fr   
Principal Investigator: Pierre DIEMUNSCH, PUPH         
Sub-Investigator: Vincent GARCIA, CCU         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pierre DIEMUNSCH, PUPH Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02558023     History of Changes
Other Study ID Numbers: 5866
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

Keywords provided by University Hospital, Strasbourg, France:
PRE-ECLAMPSIA
URAPIDIL
NICARDIPINE

Additional relevant MeSH terms:
Antihypertensive Agents
Hypertension
Pre-Eclampsia
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Benzocaine
Urapidil
Nicardipine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents